Emervel Classic Lidocaine Versus Juvederm® Ultra in Treatment of Moderate to Severe Facial Wrinkles and Folds

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-01-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare the effectiveness and safety of Emervel Classic Lidocaine versus Juvederm® Ultra in the treatment of moderate to severe facial wrinkles and folds.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Emervel® Deep Lidocaine vs. Juvederm® Ultra Plus in Treatment of Moderate to Severe Facial Wrinkles and Folds

NCT01205061

Skin Wrinkling

COMPLETED NA

Non-comparative Evaluation of Facial Expressions Following Lower Face Correction Using Emervel Classic and Emervel Deep

NCT02672644

Nasolabial Folds Wrinkles

COMPLETED PHASE4

Emervel for the Correction of Lower Face Wrinkles & Folds

NCT02718040

Nasolabial Folds Marionette Lines Wrinkles

COMPLETED PHASE4

Study of BOTOX and JUVEDERM for Treatment of Moderate to Severe Facial Wrinkles and Folds

NCT01269801

Wrinkles

COMPLETED PHASE4

Restylane + Lidocaine and Restylane Lyft for the Treatment of Nasolabial Folds

NCT04174131

Wrinkles Such as Nasolabial Folds

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Skin Wrinkling

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Emervel Classic Lidocaine

NLFs (Nasolabial Folds) were injected with Emervel Classic Lidocaine (20 mg/mL with 0.3% lidocaine).

Group Type EXPERIMENTAL

Emervel Classic Lidocaine

Intervention Type DEVICE

20 mg/mL + 0.3% lidocaine

Juvederm® Ultra

NLFs were injected with Juvéderm Ultra (24 mg/mL).

Group Type ACTIVE_COMPARATOR

Juvederm® Ultra

Intervention Type DEVICE

24mg/mL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Emervel Classic Lidocaine

20 mg/mL + 0.3% lidocaine

Intervention Type DEVICE

Juvederm® Ultra

24mg/mL

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The subject is a male or female 18 years of age or older
* The subject has bilateral nasolabial folds that, in the opinion of both the Blinded Evaluating Investigator and the Unblinded Injecting Investigator, can be corrected with an injectable dermal implant
* The subject has the same Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 (moderate or severe) for each nasolabial fold

Exclusion Criteria

* The subject has active skin disease or inflammation on or near a nasolabial fold that, in the Principal Investigator's opinion, would interfere with the study device injections and/or study assessments.
* The subject has a history of sensitivity to hyaluronic acid
* The subject has a history of sensitivity to lidocaine or other amide type anesthetics
* The subject is, in the Principal Investigator's opinion, at undue risk based on the precautions, warnings and contraindications for local lidocaine anesthetics.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No